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NCT Number: NCT06915506

Shenfu Injection Modulates Carotid Elasticity in Septic Shock

What is this study about? We are studying whether Shenfu Injection (a traditional Chinese herbal medicine) can help improve blood vessel health in patients with septic shock-a severe complication of infections that can damage blood vessels and organs. Specifically, we want to see if this treatment makes the carotid artery (a major neck blood vessel) more flexible and resilient, which may support recovery.

Who can join? Adults (18 years or older) diagnosed with septic shock by their doctors. Patients whose doctors plan to use Shenfu Injection as part of their treatment. Patients who agree to participate and sign a consent form. Who cannot join? Patients with severe heart conditions, advanced organ failure, or major neck artery disease.

Pregnant or breastfeeding women. Those unable to complete the study procedures. What will happen during the study?

Safe and Pain-Free Tests:

Ultrasound scans: A non-invasive imaging method will be used to measure the flexibility and blood flow of your neck artery.

Advanced imaging technology: A special ultrasound technique (called speckle tracking) will take detailed pictures of your artery's movement during heartbeat cycles.

Timing of Tests:

Scans will be done before receiving Shenfu Injection and 1, 2, 3 hours after the injection, plus 1 hour after treatment ends.

Other Data Collection:

Blood tests to check inflammation and organ function. Recording your health status (e.g., blood pressure, heart rate) and recovery progress (e.g., time in the Intensive Care Unit (ICU), survival rates).

What are the benefits and risks? Benefits: This study may help doctors better understand how Shenfu Injection works and improve future care for septic shock patients.

Risks: The ultrasound scans are routine, safe, and painless. There is no extra risk beyond standard hospital care.

Your Rights and Safety Voluntary Participation: You can withdraw at any time without affecting your treatment.

Ethical Approval: This study is reviewed and approved by the hospital's ethics committee.

Privacy: Your personal information and test results will be kept confidential.

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Key information

Conditions

Septic Shock Arterial Stiffness Carotid Artery Elasticity Alterations Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Vascular Dysfunction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)

Wuhu, Anhui, 241000, China

Location contact

Shengsheng Tao

CONTACT

[email protected]

86-18315329399

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Diagnosis of sepsis or septic shock in the acute phase, as defined by the -Sepsis-3 criteria (confirmed infection with Sequential Organ Failure Assessment [SOFA] score ≥ 2 points above baseline).
  • Voluntary participation with written informed consent provided by the patient or legally authorized representative.

Exclusion criteria

  • Severe carotid atherosclerosis (e.g., carotid Intima-Media Thickness (IMT)>1.2 mm or confirmed plaque formation) diagnosed by prior imaging.
  • Significant cardiovascular comorbidities that may confound hemodynamic assessments, including:
  • Severe cardiomyopathy (e.g., ejection fraction <30%).
  • Uncontrolled arrhythmias (e.g., ventricular tachycardia, atrial fibrillation with rapid ventricular response).
  • Congenital heart disease with hemodynamic instability.
  • Active hepatic or renal insufficiency (e.g., Child-Pugh class C, dialysis dependence) or advanced systemic diseases (e.g., metastatic malignancy, terminal illness).
  • Poor ultrasound image quality precluding reliable speckle tracking analysis (e.g., inadequate acoustic window, motion artifacts).
  • Pregnancy or lactation (due to potential hormonal influences on vascular physiology).
  • Withdrawal from the study or inability to complete follow-up assessments (e.g., non-compliance, transfer to another facility).

Treatment and study plan

Shenfu Injection

Drug

This intervention combines traditional Chinese medicine (TCM) with modern critical care practices to distinguish it from conventional sepsis therapies. Key unique features include:

TCM-Based Intervention:

Shenfu Injection: A standardized herbal extract derived from Panax ginseng and Aconitum carmichaelii , prepared under Chinese Pharmacopoeia guidelines.

Mechanism: Targets mitochondrial dysfunction and endothelial glycocalyx repair, with preclinical evidence of anti-inflammatory, anti-apoptotic, and vasoregulatory effects.

Precision Delivery Protocol:

Dosage: 60 mL (1 mL/kg for patients <60 kg) administered via syringe pump-controlled continuous infusion over 3 hours, ensuring stable plasma concentrations.

Timing: Initiated only after hemodynamic stabilization (≥1 hour of stable vasopressor requirements post-fluid resuscitation), aligning with the "golden window" for vascular repair in sepsis.

Primary outcomes

  1. Carotid Artery Circumferential Strain (CS)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Peak deformation of the carotid artery wall during the cardiac cycle, measured via ultrasound speckle tracking imaging (STI).Derived from strain rate analysis using dedicated vascular ultrasound software.

  2. Carotid Artery Elasticity (Beta (β)2 Stiffness Index)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Description: Composite metric integrating blood pressure and circumferential strain to quantify vascular stiffness.

    Calculation: β 2= ln(Systolic Blood Pressure/Diastolic Blood Pressure)/CS Data Sources: Blood pressure (non-invasive monitoring) + STI-derived CS.

Secondary outcomes

  1. Carotid Artery Elasticity (β1 Stiffness Index)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Calculation：β 1 = ln(Systolic Blood Pressure/Diastolic Blood Pressure)/(Ds-Dd)×Dd

  2. Carotid Artery Systolic Diameter (Ds)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Maximum diameter during systole (millimeters, mm)

  3. Carotid Artery Diastolic Diameter (Dd)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Minimum diameter during diastole (millimeters, mm)

  4. Carotid Artery Peak Systolic Velocity (PSV)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Parameter: Maximum flow velocity during systole by Doppler Ultrasound Unit: cm/s Measurement**: Pulsed-wave Doppler spectral analysis

  5. Carotid Artery End-Diastolic Velocity (EDV)

    Time frame: T0: Baseline (pre-treatment); T1: 1 hour after initiation of Shenfu Injection/control protocol ;T2: 2 hours after initiation; T3: 3 hours after initiation (end of infusion) ;T4: 1 hour post-infusion completion

    Parameter: Minimum flow velocity at end-diastole by Doppler Ultrasound Unit: cm/s Measurement**: Pulsed-wave Doppler spectral analysis

  6. ICU Length of Stay

    Time frame: up to 28 days

    Days from enrollment to ICU discharge.

  7. 28-Day All-Cause Mortality

    Time frame: Day 28 post-enrollment

    Survival status at 28 days post-enrollment.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiancheng Xu

CONTACT

[email protected]

86-18297529106

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Collaborators

  • Wuhu City Second People's Hospital

Registry information

Official study title

The Effect of Shenfu Injection on Carotid Artery Elasticity in Septic Shock Patients: A Prospective Observational Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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